Evaluation of Proprioception in Patients Treated With Surgical External Ankle Ligament Recontruction for Traumatic Ankle Instability

Not Applicable

Completed

• Conditions: Ankle Sprains; Instability, Joint
• Interventions: Device: Delos instrument (computerized balance board)

• Registration Number: NCT05868681
• Lead Sponsor: Istituto Ortopedico Rizzoli

Brief Summary

The objective of the study is to evaluate post-operatively the postural control through the Delos system with the Riva method of patients already treated surgically of external capsulo-ligament reconstruction due to ankle instability.

Detailed Description

The patients will then be divided into two control groups: one group will undergo reconditioning through the Delos system and one group will undergo standard rehabilitation treatment.

Primary outcome: improvement of joint stability and postoperative proprioception after reconditioning with the Delos system.

Secondary outcomes: improvement of performance indicators and reduction of disability and satisfaction and assessment of long-term ankle stability after reconditioning with Delos system.

Study Timeline

• Study Start: 2018-02-12
• Study First Submitted: 2018-04-12
• Primary Completion: 2019-02-12
• Study Completion: 2019-02-12
• Status Verified: 2020-04
• Study First Submitted QC: 2023-05-19
• Last Update Submitted: 2023-05-19
• Study First Posted: 2023-05-22
• Last Update Posted: 2023-05-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

Inclusion Criteria

• patients already undergoing surgery and with at least 4 months of follow-up;
• patients of both sexes aged between 18-40 years;
• patients who have given their informed written consent to participate in the study;
• patients who have given the willingness to reach the Hospital to carry out the checks.

Exclusion Criteria

• patients with BMI> 30 kg / m2;
• patients with rheumatoid arthritis;
• patients with chronic inflammatory joint diseases;
• patients with pre-existing deambulation kinematics abnormalities (amputations, neuro- muscular diseases, polio, hip dysplasias);
• patients with Severe arthrosis of the ankle (Kellgren-Lawrence> 3);
• patients with Severe knee arthritis (Kellgren-Lawrence> 3);
• patients with severe postural instability;
• patients with cognitive impairments;
• patients with concomitant neurological diseases.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Study group	Delos instrument (computerized balance board)	Proprioceptive training, which will be carried out 1 session lasting one hour twice per week for 5 weeks using Delos instrument with Riva method

Primary Outcome Measures

Name	Time	Method
Static and Dynamic Stability Index	5 weeks from the start of rehabilitation treatment	Evaluation of proprioception and mechanical stability of the post-operative ankle undergoing to reconditioning with a Delos device through Static and Dynamic Stability Index.

Secondary Outcome Measures

Name	Time	Method
Clinical test	5 weeks from the start of rehabilitation treatment	Stability of the ankle operated evaluated by clinical test
Personal perception of the patient	5 weeks from the start of rehabilitation treatment	Subjective perception of the patient evaluated by administering clinical questionnaires (AOFAS ankle hindfoot)

Trial Locations

Locations (1)

Rizzoli Orthopedic Institute (IOR); 🇮🇹 Bologna, Italy